510(k) K032798 ยท JHM Colorimetric Method, Lipoproteins
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Oct 30, 2003 |
| Received | Sep 9, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032798
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.